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A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients

NCT02290873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2020-10-20

Study results available
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Summary

A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.

Conditions

  • Colonoscopy

Interventions

DRUG

Remimazolam

For induction and maintenance of sedation

DRUG

Midazolam

For induction of maintenance and sedation

DRUG

Placebo

Inactive control arm

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Douglas K Rex, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-30
Primary Completion
2016-04-30
Completion
2016-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290873 on ClinicalTrials.gov